{"data":{"id":"us/21-cfr-878.4100","jurisdiction":"us","citation":"21 CFR 878.4100","heading":"Organ bag.","body":"(a) Identification. An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart E—Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"c263d6a0b0f24f5c9ab4fb42754b0f56efe204c4e834269220367269a18cf43a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4040","next":"us/21-cfr-878.4160"},"notice":"GroundRules: Original legal text. Not legal advice."}